Real-time tracking of cerebral hemodynamic response (rtchr) of a subject based on hemodynamic parameters

ABSTRACT

A system for measuring pain of a person, the system for use with the tissue of the person. Various sensors and detectors on the tissue provide signals to a controller for determining and indicating a pain level of the person.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is based on and claims priority from U.S. ProvisionalPatent Application Ser. No. 61/776,527, filed Mar. 11, 2013.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTINGCOMPACT DISK APPENDIX

Not Applicable

BACKGROUND

The present invention is in the medical field of blood flow and brainactivity monitoring including hemodynamic measurement. Morespecifically, the present invention is in the medical, personmanagement, animals and pets management, and pharmaceutical managementfields of measuring blood flow and cerebral hemodynamic changes andimpacts associated with several sensory stimuli including pain, braininjury, other neurological disorders, and anesthesia as well as others.

Measurement of pain can include a subjective component when a person'smood, culture, and other sociological, psychological, and other factorscontribute to sensation and reporting of pain. Some persons likeneonates, infants, children, Alzheimer persons, and/or persons underanesthesia, or in an ICU, have no mechanism of self-reporting. Also, ifpain progression could be measured and a threshold set, earlyintervention could minimize pain progression. This is also true forpersons with migraine or cluster headaches and other pains.

Pain management and treatment solutions rely on subjective data. As aresult, persons are either over-medicated or under treated. Stimulationdevices for treatment of pain could deliver more appropriate therapy ifthe stimulation level was correlated to objective, independent,reliable, and repeatable pain measurement. The evaluation and treatmentof persons occurs because many may not be able to self-report theirhealth condition, and the typical behavioral signs may be subtle orabsent.

SUMMARY

In one form, a system according to embodiments of the inventionindicates pain or a surrogate of pain symptoms of a person and is foruse with the tissue of the person. A light source is adapted forilluminating the tissue of the person. An optical sensor is adapted forsensing light emitted or reflected by the tissue of the person. Theoptical sensor generates a light signal indicative of a light parameterof the sensed light. A surface electrode is adapted for sensing anelectrical parameter of the tissue of the person. The surface electrodegenerates an electrode signal indicative of an electrical parameter ofthe sensed electrical parameter. A temperature sensor is adapted forsensing a temperature of the tissue of the person. The temperaturesensor generates a temperature signal indicative of the sensedtemperature. One or more circuits is adapted for receiving the lightsignal, the electrode signal, and the temperature signal and providescorresponding signals. A controller is adapted for receiving andprocessing the corresponding signals and is adapted for providing a painindication signal which is a function of the corresponding signals. Anindicator is adapted to be responsive to the controller for providing anindication which is indicative of the pain indication signal. A powersupply supplies power to the system.

A system for cerebral monitoring of a person and a method for providingan indication of pain of a person such as measuring pain or a surrogateof pain symptoms of a person are also presented.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a sensor system according to the system and methodand a plurality of exemplary locations for the placement of the sensorsystem on a person's forehead.

FIG. 1A is block diagram illustrating a system and method.

FIG. 2 illustrates a block diagram of the device for the real-timetracking of the cerebral hemodynamic changes on ambulatory subjectsusing the Real-time Tracking of Cerebral Hemodynamic Response (RTCHR)system.

FIGS. 3A and 3B illustrate the physics of chirp optical modulation totrack hemodynamic response changes.

FIG. 4 illustrates the period of time during which the assessments ofFIGS. 5-8 were taken.

FIG. 5 illustrates graphs of Objective Pain Level Assessment:hemodynamic changes in response to external severe cold pain stimuli.

FIG. 6 illustrates graphs of Objective Pain Level Assessment:hemodynamic changes in response to external severe heat pain stimuli.Hemodynamic response did not return to baseline due to continued burningsensation.

FIG. 7 illustrates graphs of Objective Pain Level Assessment:hemodynamic changes in response to external severe sharp pain stimuli.

FIG. 8 illustrates graphs of Objective Pain Level Assessment:hemodynamic changes in response to internal severe back pain stimuli.Subject with back pain was asked to twist his back to temporarilyincrease pain level.

FIG. 9 illustrates graphs of heart and respiration rate Estimation: Thederivative of forehead pulse can be used to estimate Heart andrespiration rates.

DETAILED DESCRIPTION

Vital signs should not be used as primary indicators of person healthcondition, but rather vital signs should be considered as a cue to beginfurther assessment. Other than vital signs, human brain reactivity toexternal/internal stimuli such as pain and anesthesia has beenextensively studied with the use mainly of magnetic resonance imagingand positron-emission tomography. However, the use of thesesophisticated methods may be unrealistic as an affordable and ambulatoryproduct for everyday use. Of interest to assessing these persons in aclinical and non-clinical setting is the noninvasive measurement ofregional cerebral tissue oxygenation with the pulse oximetry, EEG, andnear-infrared spectroscopy (NIRS) techniques. An objective of thisinvention is to develop cheaper techniques of detecting the cerebralhemodynamic characteristics and changes associated with sensory stimuli,including pain and anesthesia, among others. An objective of thisinvention is to develop a device for real-time profiling and detectionof the cerebral hemodynamic patterns and changes on an ambulatory andnon-ambulatory subjects using fully automatic and advanced machinelearning techniques. Also provided is a system that can communicate andprovide person feedback with healthcare professionals or persons toadjust the therapy or adjust other interventions.

The present invention includes a device and method for a real-timeprofiling, pattern recognition, and tracking of the cerebral hemodynamicchanges of persons (ambulatory and/or non-ambulatory) using automaticand advanced machine learning techniques to process biological datacollected using a sensor patch or a series of sensors (e.g., red andinfrared lights transmitters, and/or electroencephalography—EEG, and notlimited to other sensors such as accelerometers, position sensor,impedance sensor, and the like).

In an embodiment, a device could be designed and used for neonatalpersons where a baseline is created and deviation from brainhemodynamics and/or other sensor parameters could alarm the nurse ofinfants' discomfort which could lead to pain progression or distress.The device could be a patch with wireless data communication capability.The device could transmit and receive data from the hospital monitor.The device could also include visual, audio, or electronic feedback suchas colored LEDs, alarm, or data transmission to inform the hospitalstaff or parents of the pain or stress status of the person.

In another embodiment, the device could include an optional microphone(122; see FIG. 1A) to record neonates crying and distress levels. Thedevice could also simultaneously detect and measure the hemodynamic orother sensors levels to define a pain or cry threshold. Such a devicecould be programmed to alarm the hospital staff and parents that theneonate is progressing toward higher levels of pain and distress.Therefore, an intervention could be applied before the neonate reached amaximal pain or distress level.

In yet another embodiment, a device could be designed and developed forpersons under anesthesia undergoing surgery. These persons have nocapability to report pain. Similar to the previously described device, aprofile and threshold of the hemodynamic and other sensors could beestablished even prior to surgery when the person is awake and continueto record sensor measurements during surgery. If a device detectsdeviation from the anesthesia baseline that indicates pain orconsciousness, the anesthesiologist could adjust the drug levels tocomply with device trending and recommendation. This device could be apatch that also includes communications and person feedback, which canalso be integrated with hospital monitoring systems. In yet anotherembodiment, a device could command the anesthesiologist or theanesthesia machine to deliver additional drugs to minimize pain orsensors information deviation measured by the device. In an embodiment,all devices could be disposable or reusable.

In another embodiment, a device could be worn by an ambulatory,non-ambulatory, or mobile person where the pain management devicedirectly communicates with a control device. The control device could bea pager, a mobile phone with an app, or other variation. The controldevice could be programmed to request a measurement from the hemodynamicmeasurement device. This measurement could be programmed on hourly,daily, or other intervals. The person himself could request for anobjective pain measurement through use of the mobile device. If thepatch senses deviation from a baseline or emergence of pain is imminent,while it takes the objective measurements, it could send a signal to themobile device and request the person to include his subjective level ofpain. Such simultaneous objective and subjective pain measurement datacould be matched and used for better treatment of the person. Personscould be alarmed of a baseline deviation and a potential for theemergence or an increase in pain sensation. For example, it isunderstood if migraine pain is detected early before reachingdebilitating levels, persons can immediately intervene with medicationand or make a change in their environment to minimize pain progression.Such a device could be a noninvasive patch or an implantable deviceplaced under the hair, in forehead, or another part of the head andneck. This device could be a very thin and invisible device. Such adevice is capable of measurements on-demand, objective, and subjectivepain, and other sensor data.

Given different body positions could lead to a different type of pain(i.e., low back while standing is sensed more than lying down). In anembodiment, the device includes a position sensor. The device could alsoinclude a GPS sensor as certain environments and/or movements could leadto higher level pain inducement or sensation.

Such a device could also be used to measure a person's compliance withmedications of other therapies. The mobile device could remind theperson of taking medications on time and, within a given interval oftime, measure changes in objective pain measurements to learn if themedication was effective. Physicians can also program and/or receiveinformation about person objective, or subjective pain levels andmedication of other therapy compliance. Physicians could also commandpain level measurements both objective from the patch and subjectivefrom the mobile device app and the person. The received informationcould be used for treatment titration and compliance improvement.

The device and method could also include communications in the form of aQ&A with the person to better categorize pain, mood, stress, emotional,and behavioral variations in sensor measurements level. The sensorsresults could be matched with a person's conditions and/or environmentsto therefore provide improved person pain management. Thus, theobjective sensor measurement may be combined, synchronized, and/oraligned with a person's subjective input in a variety of environments.

It is contemplated that at least some embodiments of the devices ormethods of the invention could be implemented to aid in reducingaddictions to opiates medication, i.e., narcotics and pain killers suchas Oxycontin™ (onycodone HCl). Addiction to opiate drugs are increasingat alarming rates and causing significant issues to the healthcaresystem including rising costs, suicides, and dependencies. However, ifthese drugs are administered when the patient really needs it ratherthan at a prescribed rate, there is a possibility to reducedependencies.

It is contemplated that at least some embodiments of the devices ormethods of the invention could also help to self-discipline ordiscipline patients to administer/consume the medications when there issignificant pain on the horizon. The predictability of rising painlevels based on history of a patient could help with minimizing therequired medication to treat the pain at an early onset. Therefore, atleast some embodiments of the devices or methods of the invention couldminimize required medications for the treatment of pain.

In today's subjective pain measurement, a person is asked to rate thepain level from 1-10 in a doctor's office or another location. The sameformat of subjective pain measurements, Q&A, or other approaches can becombined into a mobile APP and synchronized with the measurement by thesystem of the invention or vice versa. A person may feel more pain inone environment or position vs. another. The system may measure the samepain level but the person's perception could be different at a differentenvironment. The system will identify these differences or changes andcreate different profiles related to mood, stress, environment, and/orpositions to help with person management. For example, one environmentmay require increased pain medication to alleviate pain. Therefore, thedevice will be intelligent enough to provide proper information to theperson. Besides measurement and monitoring of pain, this device could beused for managing a brain injury, for diagnosis of a brain injury aswell as used for sleep apnea diagnosis.

The real-time tracking of cerebral hemodynamic response (RTCHR) opticaltechnology systems, unlike pulse oximetry, uses chirp modulation in thehardware to measure the level of hemoglobin oxygenation (“oxy Hb”). TheRTCHR technology is also different than spectroscopy becausespectroscopy requires several wavelengths of light. The pulse oximeteruses the property that oxyhemoglobin and deoxyhemoglobin absorb light ofdifferent wavelengths in a specific way. A light source is provided tosequentially pass light of different wavelengths through a sample of oxyHb. A detector determines the amount of light, at each wavelength, hasbeen absorbed. Pulse oximetry uses two wavelengths (i.e., 650 and 950nm). One is a red light, which has a wavelength of approximately 650 nm.The other is an infrared light, which has a wavelength of 950 nm. Thepulse oximeter determines the oxygen saturation by comparing the amountof red light and infra-red light are absorbed by the blood. Depending onthe amounts of oxy Hb and deoxy Hb present, the ratio of the amount ofred light absorbed compared to the amount of infrared light absorbedchanges.

Functional Near-Infra-Red Spectroscopy (fNIRS) uses a similar approach,but it looks at all waveforms in a near infra-red field. Further, fNIRSuses the near-infrared region of the electromagnetic spectrum (i.e.,from about 800 nm to 2500 nm). Typical applications includepharmaceutical, medical diagnostics (including blood sugar and bloodoxygenation), food and agrochemical quality control, and combustionresearch, as well as research in functional neuroimaging, sportsmedicine & science, elite sports training, ergonomics, rehabilitation,neonatal research, brain computer interface, urology (bladdercontraction), and neurology (neurovascular coupling). In NIRS, multipleLED senders and receivers with different wavelength/light settings areused to get light reflection at different wavelengths. To get morespectrum data at more wavelengths, more LED sensors and receivers areneeded. This dramatically increases the price of the NIRS, and itincreases complexity of hardware and software.

In the present invention, lights with different wavelengths are inducedover time using frequency modulation (chirp profile) to fit the need ofa specific person or obtain most accurate hemodynamic measurements. Inthis approach, multiple LEDs are not needed, and the invention onlyneeds one pair LED transceivers and different lights are induced overtime using chirp frequency excitation of LEDs (see FIG. 3). This willmake RTCHR technology different than current pulse oximetry and existingNIRS devices, which need multiple LED senders/receivers. This will makethe technology inexpensive compared to NIRS and compatible to the costof a pulse oximetry device.

In an embodiment, the device includes the correlation of presence andlevel of pain with heart rate, temperature, brain activity, bloodpressure, or vice versa. The system measures all these parameterssimultaneously and can analyze the data to identify patterns andintelligence. The system could also correlate pain level to certainpositions, activity levels, and/or locations/environments.

The system could be used for human and animal subjects as well. Petowners have significant interests to know if their pets are experiencingpain, and if the pain management and treatment is effective. Therefore,another variation of this device could be designed and developed to fitcertain pet specifies. The system could be used for drug/pharmaceuticaldevelopment purposes as well.

Referring now to the invention in more detail, FIG. 1 shows a lateralview of the face and location of a real-time tracking of cerebralhemodynamic response (RTCHR) patch system 100 for real-time tracking ofcerebral hemodynamic response changes on an ambulatory subject. Itrecords hemodynamic response changes, heart rate, respiration, andElectroencephalogram (EEG). To localize hemodynamic response andestimate stimulus type, one or more additional patch systems 100positioned on the forehead, on the skull or other part of body can beused. In FIG. 1:

-   -   1) Optical sender/receiver unit 1A, 2B.    -   2) Standard Surface electrode 2A, 2B.    -   3) Accelerometer/GPS sensor 3.    -   4) Temperature sensor 4.    -   5) Data acquisition unit 5 to fetch data from sensors, apply any        necessary filtering, convert the sensor data in a form for        transmission to a control 7, and transmit recorded sensor data        via wired or wireless transmission to the control 7.    -   6) Display 6 such as LCD/LEDs on the patch system 100 to display        pain level and heart/respiration rates.    -   7) Control 7 fetches sensor data via wired or wireless        transmission line and applies necessary signal processing and        machine learning techniques to estimate hemodynamic parameters        in real-time while subject can do his/her normal daily        activities. It then displays the hemodynamic parameters and        stores raw and estimated results in a dedicated server. The        control box could be stand-alone or integrated with patch.

FIG. 1A is block diagram illustrating a RTCHR system 100 and method. Thesystem 100 measures pain of a person and is for use with the tissue(e.g., skin) of the person. A light source 102 is adapted forilluminating the tissue of the person. An optical sensor 104 is adaptedfor sensing light emitted or reflected by the tissue of the person. Theoptical sensor 104 generates a light signal indicative of a lightparameter of the sensed light. The light signal is indicative of pulseoxygen levels, respirations and heart rate.

A surface electrode 106 is adapted for sensing an electrical parameterof the tissue of the person. The surface electrode 106 generates anelectrode signal indicative of an electrical parameter of the sensedelectrical parameter. The electrode signal is indicative of heart rate,sweat and respirations.

A temperature sensor 108 is adapted for sensing a temperature of thetissue of the person. The temperature sensor 108 generates a temperaturesignal indicative of the sensed temperature. The temperature signal isindicative of body temperature.

One or more circuits 110 are adapted for receiving the light signal, theelectrode signal, and the temperature signal and providing correspondingsignals 112. The circuits 110 apply any necessary filtering, convert thesensor data in a form for transmission to a controller 114, and transmitrecorded sensor data via wired or wireless transmission to the control114. Thus, in one embodiment, the controller 114 includes optionaltelemetry circuitry to communicate with other devices. For example, thecontroller 114 may communicate with a mobile device such as a cell phoneor hospital monitor and provide information indicative of the signals tothe mobile device. The controller 114 is adapted for receiving andprocessing the corresponding signals and is adapted for providing a painindication signal which is a function of the corresponding signals. Anindicator 116 is adapted to be responsive to the controller 114 forproviding an indication which is indicative of the pain indicationsignal pain signal such as a signal indicative of measured pain orindicative of a surrogate of pain symptoms. [Herein, the pain indicationsignal is also referred to as a pain signal.]. A power supply 118supplies power to the system.

A motion sensor 120 is adapted for sensing a motion of the person. Themotion sensor 120 generates a motion signal indicative of the sensedmotion. The controller 114 is adapted for receiving and processing themotion signal and is adapted providing the pain signal as a function ofthe motion signal and as a function of the corresponding signals. Theindicator 116 may be driven by the circuit(s) 110 and/or by thecontroller 114. In one form, the controller is a processor having amemory device 122 storing computer executable instructions forcalculating the pain signal and wherein the processor is adapted toexecute the instructions.

In one exemplary optional form, a method for measuring pain of a personis described. The method is for use with the tissue of the person, andcomprises:

illuminating the tissue of the person;sensing light emitted or reflected by the tissue of the person;generating a light signal indicative of a light parameter of the sensedlight;sensing an electrical parameter of the tissue of the person;generating an electrode signal indicative of an electrical parameter ofthe sensed electrical parameter;sensing a temperature of the tissue of the person;generating a temperature signal indicative of the sensed temperature;processing the light signal, the electrode signal and the temperaturesignal and providing a pain signal which is a function of the processedsignals; andproviding an indication which is indicative of the pain signal.

The phrase measuring pain as used in this document is in reference tomeasuring one or more parameters that are reflective of pain. As doctorswill understand, the device does not measure pain per se but measuresone or more parameters that are reflective of pain and directly relatedto a level of pain.

In one exemplary optional form, the motion sensor comprises at least oneof an accelerometer; a GPS sensor; and a gyroscope.

In one exemplary optional form, the light source comprises at least oneof: a light source emitting light having a frequency in the range ofnear infrared wavelengths (e.g., about 1014 Hz; about 1000 nm inwavelength); an LED (light emitting diode); an LED emitting visiblelight; and an LED emitting light having a frequency in the range ofinfrared wavelengths (e.g., between 1011 to 1015 Hz; between 1000 nm to1 cm in wavelength).

In one exemplary optional form, the optical sensor comprises at leastone of: a photodetector; and a light sensitive element and the lightparameters comprise at least one of: light intensity; light frequency;light wavelength; and a light emitting pattern (chirp pattern).

In one exemplary optional form, the surface electrode comprises at leastone of: an electrode (e.g., a wet electrode, an AG/AGCL Electrode(Lead), or a dry electrode such as metal probes adapted to contact thetissue); and conductive elements adapted to contact the tissue.

In one exemplary optional form, the electrical parameters comprise atleast one of: voltage; current; resistance; capacitance; inductance;impedance; and charge.

In one exemplary optional form, the temperature sensor comprises atleast one of: a resistive temperature sensitive element; a bi-metallicelement; and a MEMS temperature sensor.

In one exemplary optional form, the one or more circuits comprise: ananalog to digital circuit; a signal conditioning circuit; a filteringcircuit; and hardware and drivers for optical transceivers in bothnormal and chirp modulation modes.

In one exemplary optional form, the light source, the optical sensor,the surface electrode, the temperature sensor and the one or morecircuits comprise one unitary, integrated component and the controlleris a separate, unitary, integrated component and further comprising awireless link between the controller and the one or more circuits.

In one exemplary optional form, the light source, the optical sensor,the surface electrode, the temperature sensor, the one or more circuits,the power supply and the controller comprise one unitary, integratedcomponent.

In one exemplary optional form, the indicator comprises at least one of:one or more LEDs; an LCD device; a screen; and a set of LEDs operatingin visible wavelength as indicators of hemodynamic change rate and/orpain level.

In one exemplary optional form, the controller comprises a processorhaving a memory device storing computer executable instructions whichestimate hemodynamic parameters and wherein the processor is adapted toexecute the instructions.

In one exemplary optional form, the hemodynamic parameters comprise atleast one of the following: hemoglobin oxygenation; hemoglobindeoxygenation; heart rate; respiration rate; forehead and/or bodytemperature; and forehead and/or body impedance.

In one exemplary optional form, the controller comprises a processorhaving a memory device storing computer executable instructions whereinthe processor processes the received, corresponding signals according toat least one of the following: instructions for an algorithm to computethe pain signal based on hemodynamic parameters and hemodynamic responseto external and/or internal stimulus in real-time or near real-time;instructions for comparing the signals to a reference (history ofhemodynamic parameters and hemodynamic response; and instructions forscaling the hemodynamic response to the range of [0, 10].

In one exemplary optional form, the instructions for the algorithmexecuted by the processor comprises instructions for fusing over apreset time interval a plurality of samples of a magnitude of the lightsignal LS, the electrode signal ES, and the temperature signal TS,adjusted by preset weights a, b, and c, to compute a pain indicativesignal PS corresponding to a fused signal according to the following:

Fused Signal=Σ(a*LS+b*ES+c*TS).

In another exemplary optional form, the instructions for the algorithmexecuted by the processor comprises instructions for using over a presettime interval a plurality of samples of a magnitude of a light painsignal LPS indicative of a pain level, an electrode pain signal EPSindicative of a pain level, and a temperature pain signal TPS indicativeof a pain level, adjusted by preset weights a, b, and c, to compute anestimated pain indicative signal PS corresponding to a fused signalaccording to the following:

Fused Signal=Σ(a*LPS+b*EPS+c*TPS).

In one exemplary optional form, the instructions for the algorithmexecuted by the processor comprises instructions for summing over apreset time interval of a plurality of samples of a magnitude of thelight signal LS, the electrode signal ES and the temperature signal TS,wherein each sample is compared to preset ranges and the magnitude ofthe signals is adjusted according to a relationship between each signaland the preset ranges.

In one exemplary optional form, the instructions comprise instructionsfor inputting personal input into the controller by an input device suchas a keypad or keyboard, the personal input including conditions and/orenvironments of the person and wherein the pain signal is coordinatedwith the personal input whereby improved person pain management isprovided.

In one exemplary optional form, the personal input includes a level ofconsciousness indicator, such as:

0 Awake; 2 Light/Moderate Sedation; 4 General Anesthesia; 6 DeepHypnotic State; 8 Burst Suppression; and

10 Fully unconscious.

In one exemplary optional form, the controller processes at least one ofthe corresponding signals according to chirp based optical modulation.

In one exemplary optional form, the optical sensor comprises a bloodoxygenation sensor for sensing a blood oxygenation of the person andwherein the chirp based optical modulation by the processor comprisesmeasuring the light signal in different wavelengths as indicative ofblood oxygenation.

In one exemplary optional form, the chirp based optical modulationcomprises varying a carrier frequency in optical modulation over time tomimic hemodynamic response in different wavelengths over time to detecthemodynamic response recursively over time in a serial (recursive)approach.

In one exemplary optional form, the controller calculates respirationsand heart rate by evaluating different frequency components in rawsensor data from the optical sensor.

In one exemplary optional form, a respiratory signal has a frequencycomponent of the raw data [2-5 Hz] which can be extracted using a bandpass frequency with cut off [2-5 Hz], and wherein the processorevaluates frequency components of 5-100 Hz to obtain heart rate.

In one exemplary optional form, the controller comprises a processorhaving a memory device storing computer executable instructionscomprising machine learning techniques and wherein the processor isadapted to execute the instructions, wherein the machine learningtechniques include at least one of: adaptive and non-adaptive noisecancellation of noise in the signals; signal Envelope Detection; lowpass, band-pass, band-stop and high pass digital filters to extractdifferent hemodynamic parameters from sensor data spectrum; andsupervised or unsupervised clustering including at least one of k-means,fuzzy c-means artificial neural networks, support vector machine, fuzzysystems to characterize hemodynamic response across different persons(persons) and across days (inter and intra subject variabilitycharacterization).

In one exemplary optional form, the controller calibrates the systemusing a baseline wander correction algorithm based on at least one ofadaptive or non-adaptive filtering.

In one exemplary optional form, data is provided to the controllerindicative of feedback from a person to train the controller or set arange.

In one exemplary optional form, the data comprises subjective painmeasurements from the person synchronized with pain indicatormeasurements by the system, wherein the subjective pain measurementcomprise:

0-1 No pain;2-3 Mild pain;4-5 Discomforting—moderate pain;6-7 Distressing—severe pain;8-9 Intense—very severe pain;10 Unbearable pain.

In one exemplary optional form, the controller synchronizes objectivehemodynamic parameters of the sensor signals with subjectivemeasurements provided by the person so that the sensor and person or aphysician establishes communication and coordination between the sensorsand the person or physician.

In one exemplary optional form, the controller generates commands towhich the person responds to at a particular point to define a baseline.For example, the device will continuously or at programmed intervals askthe person to respond to the device by defining his subjective painlevel through a mobile phone or other communication interface. As aresult, the device/system is capable of calibrating/coordinating itsobjective measurements with the person's subjective measurements. Thisprocess will also help with baseline creation so that the objective andsubjective pain levels correlate at the moment in time.

In one exemplary optional form, the controller is responsive to a personor physician to trigger the hemodynamic monitor to make measurements anddefine a baseline.

In one exemplary optional form, a person indicates his/her pain statusamong environmental parameters to train the device for thresholddefinition.

In one exemplary optional form, the device communicates with the personsregarding its pain status in order to define a baseline and thresholdfor device training and personalization.

In one exemplary optional form, the system is configured to beimplantable within a person. One device variation could be a singlepatch placed on the person forehead, head, or neck. Another optionalvariation could be multiple sensors being placed on the forehead orcircumference of the head similar to a bandana. Yet another optionalvariation of the device and method could be an implantable device withsensors and battery and wireless operation that can be continuous oractivated by mobile phone or any other activator to activate the sensorfor a programmed period of time and transmit information to the receiveroutside or inside the body. The implantable device could be rechargeableover the scalp. This implantable device could be implanted underneathhair in or underneath the scalp via a simple insertion like a hairpin orincision. The implantable device will be removable as well. Implantabledevice could have flat or other geometrical form factors to fit theperson's head/scalp/skull. The receiver device could be a mobile phone,a hat, headband, or other similar form factors. The implantable devicecould be powered using an external power source such as an RF generatoror coil-to-coil power generation where a capacitor in the device storesenough energy to perform a required measurement and transmission of theinformation.

In further detail, referring to FIG. 2, the Real-Time Tracking ofCerebral Hemodynamic Response (RTCHR) system 100 includes three stages.A first stage 202 employs a sensor unit for recording data. The sensorunit includes, for example, a surface electrode and opticalsender/receiver LEDs, an accelerometer, a GPS, and temperature sensors.The sensor data are processed and properly conditioned in the next stage204 and then, with a wired or wireless transmission unit, the sensordata are transferred at a third state 206 to a control for furtherprocessing (e.g., advance real-time signal processing and machinelearning) to estimate hemodynamic response changes due toexternal/internal stimulus (anesthesia, pain, and the like), heart rate,respiration and other parameters. The advance real-time signalprocessing stage includes real-time denoising, baseline wander removal,extraction of different band of sensor data related to heart pulse,respiration and/or cerebral hemodynamic response trace based onfrequency domain filtering envelop detection and real-time sourceseparations. To estimate hemodynamic response change over time somestatistical and morphological features such as norm, root-mean-square,skewness, kurtosis, entropy, and the like are extracted and input to areal-time machine learning stage to compare blood oxygen consumptionpattern between present and past. Also, machine learning basedpredictive models can be used to predict onset of pain in the closefuture in pain management applications.

The advantage of the current invention as compared to other digitalinterfaces is that in one embodiment of the invention a single foreheadpatch can be used to estimate hemodynamic parameters using a new opticalmodulation which makes it different compared to current optical sensingsuch as oximetry and functional near-infrared (fNIR) technology devices,such as shown in FIG. 3A. FIG. 3A illustrates on the left a graph of theabsorption of spectra of oxy-Hb and deoxy-Hb in the near infrared range(the three graphical lines illustrate HbO₂, Hb, and water, from left toright). FIG. 3A on the right illustrates the path of light on a humanhead from emitter to detector. A chirp signal such as illustrated inFIG. 3B is used to emit light with different wavelengths in red and nearinfra-red ranges. By use of chirp modulation according to the invention,tracking of hemodynamic response changes will be maximized and RTCHRprovides a new class of optical sensing compared to oximetry andspectroscopy.

Chirp based optical modulation according to one aspect of the inventionmeasures blood oxygenation in different wavelengths. In chirpmodulation, a carrier frequency in optical modulation varies over timeto mimic hemodynamic response in different wavelengths over time. Incontrast, in oximetry, only two wavelengths are used and in NIRspectroscopy a set of optical senders and receivers are used to gethemodynamic responses over different wavelengths in parallel. Chirpbased optical modulation according to one aspect of the inventiondetects hemodynamic response recursively over time. Since hemodynamicresponse is slow, the system detects hemodynamic responses overdifferent wavelengths in a serial (recursive) approach. Modulationpattern and number and range of frequency (wavelength) modulation can becontrolled by a person at software level, but hardware for chirpmodulation may also be used to implement control. For instance, a personcould take two wavelengths readings, one in red field and another innear-infra red. On this case, the device acts as a pulse oximeter. Inother words, the system with its novel recursive modulation ability caninduce any pattern including two wavelength readings (oximeter mode) orchirp mode (multiple wavelengths reading).

It is noteworthy that the single forehead patch could include several ofthe hemodynamic and other sensors for multiple measurements acrossdifferent locations on the forehead or the brain.

A typical application for RTCHR system 100 and method according to theinvention provide objective pain level assessment. Currently in clinics,persons are asked to score their pain level to a number between 0-10:1-3: mild pain, 4-7 moderate pain and 8-10 sever pain. The system 100and its method are capable of estimating pain level by trackinghemodynamic baselines and/or changes in response to internal/externalpain stimulus. For example, in one embodiment, previous sensor readingsfrom few minutes and/or hours ago are used as baseline hemodynamicresponse and the current sensor reading is compared with the history ofdata to determine level of deviation. Alternatively and in addition, abaseline could be arbitrary. If a nurse, doctor, or the person startsbaseline recording at a certain point in time or under certainconditions, this also could be considered baseline. The device/systemwill allow a person (e.g., person, doctor, technician) to choose and setup a certain condition as “baseline”. Yet, when an infant cries or is instress due to pain, the higher level or threshold could be consideredbaseline, too, not necessarily the lowest measurement. Thus, a baselineis a reference, either arbitrary or defined.

In general, a baseline is a reference point. For example, a baseline maybe established in several ways. 1) When the subject is in a normal stateor in pain. In a normal state, any increase in pain is tracked; in apain state, increases or decrease in pain due to therapy are tracked. 2)In a situation where there is previous data from a person, the data maybe used to establish a baseline, such as body temperature or bloodpressure. For example, one day data could be used to establish a normalrange of body temperature.

To demonstrate the ability of RTCHR to estimate pain levels, subjectdata using the forehead patch as shown in FIG. 1, before, during andafter an external pain stimulus (e.g., sever cold, heat and sharp pains)were recorded. FIGS. 5-8 illustrate the recorded data, showing thehemodynamic changes in response to external and internal pain stimulus.The Y-axis is an estimated pain level (1st norm scaled to 0-10) persecond for first and second subplots and per 10 second for the thirdsubplot. FIG. 4 illustrates the period of time during which theassessments of FIGS. 5-8 were taken.

FIG. 5 illustrates graphs of Objective Pain Level Assessment:hemodynamic changes in response to external severe cold pain stimuli.Levels 1-10 during the first 20 seconds illustrate the baseline. Levels11-20 during the next 20 seconds illustrate the response during painstimulus. Levels 21-30 during the last 20 seconds illustrate theresponse during recovery after pain stimulus has ended.

FIG. 6 illustrates graphs of Objective Pain Level Assessment:hemodynamic changes in response to external severe heat pain stimuli.Hemodynamic response did not return to baseline due to continued burningsensation. Levels 1-10 during the first 20 seconds illustrate thebaseline. Levels 11-20 during the next 20 seconds illustrate theresponse during pain stimulus. Levels 21-30 during the last 20 secondsillustrate the response during recovery after pain stimulus has ended.

FIG. 7 illustrates graphs of Objective Pain Level Assessment:hemodynamic changes in response to external severe sharp pain stimuli.Levels 1-10 during the first 20 seconds illustrate the baseline. Levels11-20 during the next 20 seconds illustrate the response during painstimulus. Levels 21-30 during the last 20 seconds illustrate theresponse during recovery after pain stimulus has ended.

FIG. 8 illustrates graphs of Objective Pain Level Assessment:hemodynamic changes in response to internal severe back pain stimuli.Subject with back pain was asked to twist his back to temporarilyincrease pain level. Levels 1-10 during the first 20 seconds illustratethe baseline. Levels 11-20 during the next 20 seconds illustrate theresponse during pain stimulus. Levels 21-30 during the last 20 secondsillustrate the response during recovery after pain stimulus has ended.

The RTCHR system 100 and its method also provide heart and respirationrates. FIG. 9 illustrates graphs of heart and respiration rateEstimation: The derivative of forehead pulse can be used to estimateHeart and respiration rates. FIG. 9 shows a typical forehead pulse andestimated heart and respiration rates. To calculate respiration andheart rate, the processor evaluates different frequency components inraw sensor data from the optical sensor. A respiratory signal is afrequency component of the raw data [2-5 Hz] which can be extractedusing a band pass frequency with cut off [2-5 Hz]. To get heart rate,the processor evaluates frequency components of 5-100 Hz.

Heart rate and/or respiration rate can be measured or calculatedmanually or automatically. In one embodiment, respiration rate and heartrate signals can be extracted from a light signal and/or surfaceelectrode signal and for analysis according to at least some embodimentsof the systems and methods of the invention.

Another application for RTCHR is in the area of sensation as associatedwith brain activity. Images in movies and photos can generate empathicpain. Subjects shown a series of images or movies with injuries or otherpain related events have reported definite pain to at least one image ofmovie. It has been determined that subjects who report pain in responseto such images activate pain matrix regions in the brain, which areresponsible for generating pain. Therefore, observing painful imagesmodulates motor responses, which suggest sensorimotor involvement. Forexample, a person reported feeling physical pain when observing his wifeexperience superficial pain. Various types of pain have been measured,for instance, somatic pain (e.g., tingling, aching, sharp, shooting,throbbing, sickening, splitting, heavy, stabbing, and tender types ofpain have been described) and visceral pain. Further, rCBF response toheighted unpleasantness has been recorded. Pain activates a large amountof neural tissue. However, understanding chronic pain is unresolved.Imaging studies have illustrated that chronic pain is associated withfunctional, structural and chemical changes in the brain; however, it isnot known how neural activity is translated into a feeling. Areas of thebrain that are usually active provide for pain inhibition, and a lack ofpain inhibition causes chronic pain. In addition, dysfunctionalpsychological processing changes underlying patterns of brain activationand causes chronic pain. Typically, pain is reported by askingsubjective questions of persons and not by imaging anatomic informationand determining the activation of brain distress centers. RTCHR may beused to better evaluate and understand these aspects.

Studies have been made using a functional Magnetic Resonance Imaging(“fMRI”) scanner to study pain. The fMRI records the variable magneticproperty of tissue. For instance, fMRI scanning has been utilized duringthe presentation of real noxious heat stimuli, as well as during thesuggestion of a real noxious heat stimuli to a set of eight subjects.All the subjects reported a sensation of at least heat during thesuggestion and five reported pain. In addition, fMRI can determine theBlood Oxygen Level Dependent (BOLD) signal, which measures an “effectparameter”. However, a disadvantage of using BOLD is that the signalchanges are small making the analysis difficult, tedious andcomplicated, requiring significant subjectivity. RTCHR may be used tobetter evaluate and understand these aspects.

fMRI has been used to study empathetic pain. For instance, ten painresponders and ten non-responders acting as controls were give a set ofpain images and a set of emotional images. Using fMRI the anteriormidcingulate cortex (“aMCC”) was monitored. The responders consistentlyactivated aMCC, anterior insula, prefrontal cortex and primary (S1) andsecondary (S2) somatosensory cortex for all pain images and emotionalimages. In contrast, the non-responders consistently activated aMCC andprefrontal cortex but failed to activate insula, S1 or S2. Therefore,regional activation is specifically and actively involved in thegeneration of pain, and empathetic pain appears to involve the samemechanism. For example, using hypnosis one can direct generation of painvia the usual pain neuromatrix. Once again, RTCHR may be used to betterevaluate and understand these aspects. Instead of using fMRI, applyingRTCHR provides objective measurements hemodynamic response, heart andrespiration rates, to determine and predict the onset of pain.

It is known that brain lesions can cause pain. In addition, it is knownthat newborns have an exaggerated sensitivity to touch that diminisheswith maturity. Further, it has been determined that blocking descendinginhibition in animals causes hyperalgesia. Thus it is possible thatfunctional pain is caused by a disruption to descending inhibition. fMRIhas also been used to study offset analgesia. Offset analgesia is theperception of profound analgesia during a slight incremental decrease ofa noxious heat stimulus that is more pronounced than would be predictedby the rate of the temperature decrease. Offset analgesia is an activeprocess probably involving descending inhibitory mechanisms to modulatepain. Using fMRI, twelve control subjects, free of neurological disorderand chronic pain, completed an offset analgesia procedure. Theycompleted the offset procedure six times; twice at each temperature(high, medium, and low). The results indicated that: 1) during baseline,there is little pain and little activation; 2) during constant, there ispain and plenty of pain activation; and 3) during offset there is lesspain and little activation. Therefore, one can conclude that normalcontrols can be induced to feel pain without any physically noxiousstimulus. Functional pain person might generate pain in a similarfashion. Also, normal controls can be induced to feel a noxious stimulusas less painful without any physical change in the stimulus. Therefore,functional pain persons may lack endogenous analgesic mechanisms such asoffset analgesia. RTCHR may be used to better evaluate and understandthese aspects.

It is possible to utilize a device of the invention to measure issueswith brain development in neonates. Some neonates have problems withnormal development of the brain and the device is helpful to detect andreport such issues despite whether the neonate feels pain or not. Forexample, a “normal” level of sensor measurement expected in a largergroup of neonates (expected baseline data) can be used as a baseline tocompare to other neonates who have severe deviation from the baseline.In addition, the device may be used for cerebral monitoring such as aparticular brain function monitoring instead of the pain application.For example, the device in at least certain persons may indicate ordetect early onset of epilepsy or another brain related issues (e.g.,Alzheimer, Parkinson's, brain tumors). Thus, the device may be used tocapture early onset of epilepsy or another brain related issues in aninexpensive and ambulatory way by use of a single patch on a forehead ora person or at other locations on the body. In this context, the painsignal comprises a cerebral monitoring signal.

It is also contemplated that the device may be used by athletes forperformance enhancement as it relates to cerebral flow and painperception.

Feedback

In one aspect, feedback from the person may be used to train the system100 or set a range. Also, a person may choose which days/time should becompared with current time [reference point and baseline setting]. Also,a person's subjective pain level can be compared with objective(automated) pain assessment. This is called interactive pain. Enabledwith artificial intelligence and real-time learning mode, this appliesself-tuning, particularly when there is a large difference betweenobjective and subject pain levels.

Oximeter/Device Combination

In one embodiment, a pulse oximeter can be modified to also provide acerebral hemodynamic tracking system according to the invention tomeasure pain, trauma, epilepsy, level of consciousness, attentionmonitoring and other brain related applications. For example, the pulseoximeter is modified to detect a light signal, an electrical parameterelectrode signal and a temperature signal. In addition, the firmware ofpulse oximeter is updated to have access to raw data from LEDs and applyan algorithm for generating a pain signal which is a function of thecorresponding signals and for providing an indicator indicative of thepain signal.

Calibration

In one form, baseline wander correction algorithms (based on adaptive ornon-adaptive filtering techniques) may be used to performself-calibration and to account for sensor data drift coming fromhardware and/or human condition changes such as sweating or motion.

Another application of at least some embodiments of the device or methodof the invention is in various product configurations for the OBGYNapplications. For example, a consumer patch and a smart phone app couldbe used to track uterus contractions prior to childbirth. In today'senvironment, expectant mothers have to record the frequency of theuterus contractions and keep a record with a timer in hand. Oncecontractions happen too closely, it will be time to attend a clinic orhospital for child delivery. So often expectant mothers miss the truecontraction frequency and associated pain level. Uterus contractionscause proportional pain. At least some embodiments of the device ormethod of the invention attached to the forehead could keep track of thepain associated with the uterus contractions and maintain a concise timeand pain amplitude profile without a subject's intervention. As aresult, at least some embodiments of the device or method of theinvention could advise the subject when to attend to the clinic whilesimultaneously transmitting the complete contraction profile to theclinic or the attending doctors prior to arrival.

At least some embodiments of the device or method of the invention couldbe used for epidural pain management to measure pain and automaticallyadminister pain medication.

At least some embodiments of the device or method of the invention couldbe used for post childbirth pain management in natural or C-section typechildbirth where pain management is a major issue. All data collectedcan be integrated into a patient profile at the hospital EMR.

Yet another application could be a handheld device for tracking childrenpain due to teething or other painful situations to assist parents inmanaging children or infant pain. At least some embodiments of thedevice or method of the invention could be similar to a handheldthermometer with memory. Routine baseline measurements can be recorded.Once the infant is in a stressful situation and crying for no apparentreason, parents can place the device on the forehead for a period oftime to measure if pain is present. At least some embodiments of thedevice or method of the invention could be used on neonates at thehospitals or non-responders in ICU and nursing homes.

Yet another application is in post-surgery where a patient's pain isbeing managed by a PCA (patent controlled analgesia) infusion pump. Manypost-surgery cases involve keeping a patient at a hospital for 3-7 days,connected to a PCA pump where the patient controls the amount of painmedication delivery. While this is very efficient compared to a presetinfusion rate, in many situations when a patient falls sleep for 8-12hours, the lack of pain management leads to adverse events such asinflammation or other causes of chronic pain. In these situations, ifthe acute pain is not treated properly, it can translate to chronic painwhich is inconvenient to the patient and costly the healthcare system.

At least some embodiments of the device or method of the invention couldbe programmed to either administer a drug by instructing the infusion todeliver more medication, wake the patient up by sound or other stimulus,or send a notification to the nursing station. Therefore, pain ismanaged continuously even when patients are sleep. All data from thedevice will be integrated into the hospital EMR.

Yet another application is in pain medication drug discovery. Painmedication drug discovery today is a cumbersome process. During clinicaltrials, a patient is asked for a subjective pain level in order to learnif the drug is effective. So often this type of drug discovery leads tofailure due to a placebo effect or improper subjective pain levelreporting. Utilizing at least some embodiments of the device or methodof the invention, a majority of the ambiguity in pain drug discoveriescould be resolved. Companies also can receive real-time effect of theirnewly developed pain medications from subjects and patients enrolled inclinical trials in real-time.

Yet another variation of At least some embodiments of the device ormethod of the invention could be to identify and diagnose otherneurological disorders such as onset or prediction of bipolar disorder,mood change, schizophrenia, and/or depressions.

The Abstract and summary are provided to help the reader quicklyascertain the nature of the technical disclosure. They are submittedwith the understanding that they will not be used to interpret or limitthe scope or meaning of the claims. The summary is provided to introducea selection of concepts in simplified form that are further described inthe Detailed Description. The summary is not intended to identify keyfeatures or essential features of the claimed subject matter, nor is itintended to be used as an aid in determining the claimed subject matter.

For purposes of illustration, programs and other executable programcomponents, such as the operating system, are illustrated herein asdiscrete blocks. It is recognized, however, that such programs andcomponents reside at various times in different storage components of acomputing device, and are executed by a data processor(s) of the device.

Although described in connection with an exemplary computing systemenvironment, embodiments of the aspects of the invention are operationalwith numerous other general purpose or special purpose computing systemenvironments or configurations. The computing system environment is notintended to suggest any limitation as to the scope of use orfunctionality of any aspect of the invention. Moreover, the computingsystem environment should not be interpreted as having any dependency orrequirement relating to any one or combination of components illustratedin the exemplary operating environment. Examples of well-known computingsystems, environments, and/or configurations that may be suitable foruse with aspects of the invention include, but are not limited to,personal computers, server computers, hand-held or laptop devices,multiprocessor systems, microprocessor-based systems, set top boxes,programmable consumer electronics, mobile telephones, network PCs,minicomputers, mainframe computers, distributed computing environmentsthat include any of the above systems or devices, and the like.

Embodiments of the aspects of the invention may be described in thegeneral context of data and/or processor-executable instructions, suchas program modules, stored one or more tangible, non-transitory storagemedia and executed by one or more processors or other devices.Generally, program modules include, but are not limited to, routines,programs, objects, components, and data structures that performparticular tasks or implement particular abstract data types. Aspects ofthe invention may also be practiced in distributed computingenvironments where tasks are performed by remote processing devices thatare linked through a communications network. In a distributed computingenvironment, program modules may be located in both local and remotestorage media including memory storage devices.

In operation, processors, computers and/or servers may execute theprocessor-executable instructions (e.g., software, firmware, and/orhardware) such as those illustrated herein to implement aspects of theinvention.

Embodiments of the aspects of the invention may be implemented withprocessor-executable instructions. The processor-executable instructionsmay be organized into one or more processor-executable components ormodules on a tangible processor readable storage medium. Aspects of theinvention may be implemented with any number and organization of suchcomponents or modules. For example, aspects of the invention are notlimited to the specific processor-executable instructions or thespecific components or modules illustrated in the figures and describedherein. Other embodiments of the aspects of the invention may includedifferent processor-executable instructions or components having more orless functionality than illustrated and described herein.

The order of execution or performance of the operations in embodimentsof the aspects of the invention illustrated and described herein is notessential, unless otherwise specified. That is, the operations may beperformed in any order, unless otherwise specified, and embodiments ofthe aspects of the invention may include additional or fewer operationsthan those disclosed herein. For example, it is contemplated thatexecuting or performing a particular operation before, contemporaneouslywith, or after another operation is within the scope of aspects of theinvention.

When introducing elements of aspects of the invention or the embodimentsthereof, the articles “a,” “an,” “the,” and “said” are intended to meanthat there are one or more of the elements. The terms “comprising,”“including,” and “having” are intended to be inclusive and mean thatthere may be additional elements other than the listed elements.

In view of the above, it will be seen that several advantages of theaspects of the invention are achieved and other advantageous resultsattained.

Not all of the depicted components illustrated or described may berequired. In addition, some implementations and embodiments may includeadditional components. Variations in the arrangement and type of thecomponents may be made without departing from the spirit or scope of theclaims as set forth herein. Additional, different or fewer componentsmay be provided and components may be combined. Alternatively or inaddition, a component may be implemented by several components.

The above description illustrates the aspects of the invention by way ofexample and not by way of limitation. This description enables oneskilled in the art to make and use the aspects of the invention, anddescribes several embodiments, adaptations, variations, alternatives anduses of the aspects of the invention, including what is presentlybelieved to be the best mode of carrying out the aspects of theinvention. Additionally, it is to be understood that the aspects of theinvention is not limited in its application to the details ofconstruction and the arrangement of components set forth in thefollowing description or illustrated in the drawings. The aspects of theinvention are capable of other embodiments and of being practiced orcarried out in various ways. Also, it will be understood that thephraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting.

Having described aspects of the invention in detail, it will be apparentthat modifications and variations are possible without departing fromthe scope of aspects of the invention as defined in the appended claims.It is contemplated that various changes could be made in the aboveconstructions, products, and methods without departing from the scope ofaspects of the invention. In the preceding specification, variouspreferred embodiments have been described with reference to theaccompanying drawings. It will, however, be evident that variousmodifications and changes may be made thereto, and additionalembodiments may be implemented, without departing from the broader scopeof the aspects of the invention as set forth in the claims that follow.The specification and drawings are accordingly to be regarded in anillustrative rather than restrictive sense.

What is claimed is:
 1. A system for providing an indication of pain of aperson such as measuring pain or a surrogate of pain symptoms of aperson, said system for use with the tissue of the person, said systemcomprising: A light source adapted for illuminating the tissue of theperson; An optical sensor adapted for sensing light emitted or reflectedby the tissue of the person, said optical sensor generating a lightsignal indicative of a light parameter of the sensed light; A surfaceelectrode adapted for sensing an electrical parameter of the tissue ofthe person, said surface electrode generating an electrode signalindicative of an electrical parameter of the sensed electricalparameter; A temperature sensor adapted for sensing a temperature of thetissue of the person, said temperature sensor generating a temperaturesignal indicative of the sensed temperature; One or more circuitsadapted for receiving the light signal, the electrode signal, and thetemperature signal and providing corresponding signals; A controlleradapted for receiving and processing the corresponding signals andadapted for providing a pain indication signal which is a function ofthe corresponding signals; An indicator adapted to be responsive to thecontroller for providing an indication which is indicative of the painindication signal; and A power supply for supplying power to the system.2. The system of claim 1 further comprising a motion sensor adapted forsensing a motion of the person, said motion sensor generating a motionsignal indicative of the sensed motion; and wherein the controller isadapted for receiving and processing the motion signal and is adaptedproviding the pain indication signal as a function of the motion signaland as a function of the corresponding signals.
 3. The system of claim 2wherein the motion sensor comprises at least one of: an accelerometer; aGPS sensor; and a gyroscope.
 4. The system of claim 1 wherein the lightsource comprises at least one of: A light source emitting light having afrequency in the range of near infrared wavelengths (e.g., about 10¹⁴Hz; about 1000 nm in wavelength); An LED; An LED emitting visible light;and An LED emitting light having a frequency in the range of infraredwavelengths (e.g., between 10¹¹ to 10¹⁵ Hz; between 1000 nm to 1 cm inwavelength).
 5. The system of claim 1 wherein the optical sensorcomprises at least one of: A photodetector; and A light sensitiveelement.
 6. The system of claim 1 wherein the light parameters comprisesat least one of: Light intensity; Light frequency; Light wavelength; andA light emitting pattern (chirp pattern).
 7. The system of claim 1wherein the surface electrode comprises at least one of: an electrode;and Conductive elements adapted to contact the tissue.
 8. The system ofclaim 1 wherein the electrical parameters comprises at least one of:Voltage; Current; Resistance; Capacitance; Inductance; Impedance; andCharge.
 9. The system of claim 1 wherein the temperature sensorcomprises at least one of: A resistive temperature sensitive element; Abi-metallic element; and A MEMS temperature sensor.
 10. The system ofclaim 1 wherein the one or more circuits comprise: An analog to digitalcircuit; A signal conditioning circuit; A filtering circuit; andHardware and drivers for optical transceivers in both normal and chirpmodulation modes.
 11. The system of claim 1 wherein the light source,the optical sensor, the surface electrode, the temperature sensor andthe one or more circuits comprise one unitary, integrated component andthe controller is a separate, unitary, integrated component and furthercomprising a wireless link between the controller and the one or morecircuits.
 12. The system of claim 1 wherein the light source, theoptical sensor, the surface electrode, the temperature sensor, the oneor more circuits, the power supply and the controller comprise oneunitary, integrated component.
 13. The system of claim 1 wherein theindicator comprises at least one of: One or more LEDs; An LCD device; Ascreen; and A set of LEDs operating in visible wavelength as indicatorsof hemodynamic change rate and/or pain level.
 14. The system of claim 1wherein the controller comprises a processor having a memory devicestoring computer executable instructions which estimate hemodynamicparameters and wherein the processor is adapted to execute theinstructions.
 15. The system of claim 14 wherein the hemodynamicparameters comprise at least one of the following: hemoglobinoxygenation; hemoglobin deoxygenation; heart rate; respiration rate;forehead and/or body temperature; and forehead and/or body impedance.16. The system of claim 1 wherein the controller comprises a processorhaving a memory device storing computer executable instructions whereinthe processor processes the received, corresponding signals according toat least one of the following: instructions for an algorithm to computethe pain indication signal based on hemodynamic parameters andhemodynamic response to external and/or internal stimulus in real-timeor near real-time; instructions for comparing the signals to a reference(history of hemodynamic parameters and hemodynamic response; andinstructions for scaling the hemodynamic response to the range of [0,10].
 17. (canceled)
 18. (canceled)
 19. The system of claim 16 wherein atleast one of the following: the instructions for the algorithm executedby the processor comprises instructions for fusing over a preset timeinterval a plurality of samples of a magnitude of the light signal LS,the electrode signal ES and the temperature signal TS, adjusted bypreset weights a, b, and c, to compute a pain indicative signal PScorresponding to a fused signal according to the following: FusedSignal=Σ(a*LS+b*ES+c*TS); and the instructions for the algorithmexecuted by the processor comprises instructions for using over a presettime interval a plurality of samples of a magnitude of a light painsignal LPS indicative of a pain level, an electrode pain signal EPSindicative of a pain level, and a temperature pain signal TPS indicativeof a pain level, adjusted by preset weights a, b, and c, to compute anestimated pain indicative signal PS corresponding to a fused signalaccording to the following: Fused Signal=Σ(a*LPS+b*EPS+c*TPS).
 20. Thesystem of claim 16 wherein the instructions for the algorithm executedby the processor comprises instructions for summing over a preset timeinterval of a plurality of samples of a magnitude of the light signalLS, the electrode signal ES and the temperature signal TS, wherein eachsample is compared to a preset range and the magnitude of the signals isadjusted according to a relationship between each signal and the presetrange.
 21. The system of claim 1 further comprising instructions forinputting personal input into the controller by an input device such asa keypad or keyboard, said personal input including conditions and/orenvironments of the person and wherein the pain indication signal iscoordinated with the personal input whereby improved person painmanagement is provided.
 22. The system of claim 16 wherein the personalinput includes a level of consciousness indicator, such as: 0 Awake; 2Light/Moderate Sedation; 4 General Anesthesia; 6 Deep Hypnotic State; 8Burst Suppression; and 10 Fully unconscious.
 23. The system of claim 1the controller processes at least one of the corresponding signalsaccording to chirp based optical modulation.
 24. The system of claim 1wherein the optical sensor comprises a blood oxygenation sensor forsensing a blood oxygenation of the person and wherein the chirp basedoptical modulation by the processor comprises measuring the light signalin different wavelengths as indicative of blood oxygenation.
 25. Thesystem of claim 1 wherein the chirp based optical modulation comprisesvarying a carrier frequency in optical modulation over time to mimichemodynamic response in different wavelengths over time to detecthemodynamic response recursively over time in a serial (recursive)approach.
 26. The system of claim 1 wherein the controller calculatesrespirations and heart rate by evaluating different frequency componentsin raw sensor data from the optical sensor.
 27. The system of claim 1wherein a respiratory signal is a frequency component of the raw data[2-5 Hz] which can be extracted using a band pass frequency with cut off[2-5 Hz], and wherein the processor evaluates frequency components of5-100 Hz to get heart rate.
 28. The system of claim 1 wherein thecontroller comprises a processor having a memory device storing computerexecutable instructions comprising machine learning techniques andwherein the processor is adapted to execute the instructions, whereinsaid machine learning techniques includes at least one of: Adaptive andnon-adaptive noise cancellation of noise in the signals; Signal EnvelopeDetection; Low pass, band-pass, band-stop and high pass digital filtersto extract different hemodynamic parameters from sensor data spectrum;and supervised or unsupervised clustering including at least one ofk-means, fuzzy c-means artificial neural networks, support vectormachine, fuzzy systems to characterize hemodynamic response acrossdifferent persons (persons) and across days (inter and intra subjectvariability characterization).
 29. The system of claim 1 wherein thecontroller calibrates the system using a baseline wander correctionalgorithm based on at least one of adaptive or non-adaptive filtering.30. The system of claim 1 further comprising providing data to thecontroller indicative of feedback from a person to train the controlleror set a range.
 31. The system of claim 30 wherein the data comprisessubjective pain measurements from the person synchronized with painindicator measurements by the system, wherein the subjective painmeasurement comprise: 0-1 No pain; 2-3 Mild pain; 4-5Discomforting—moderate pain; 6-7 Distressing—severe pain; 8-9Intense—very severe pain; 10 Unbearable pain.
 32. The system of claim 1wherein the controller synchronizes objective hemodynamic parameters ofthe sensor signals with subjective measurements provided by the personso that the sensor and person or a physician establish communication andcoordination between the sensors and the person or physician.
 33. Thesystem of claim 1 at least one of the following: wherein the controllergenerates commands to which the person responds to at a particular pointto define a baseline. wherein the controller is responsive to a personor physician to trigger the hemodynamic monitor to make measurements anddefine a baseline. wherein a person indicates his/her pain status amongenvironmental parameters to train the device for threshold definition.wherein the device communicates with the persons regarding its painstatus in order to define a baseline and threshold for device trainingand personalization.
 34. The system of claim 1 wherein said system isconfigured to be implantable within a person.
 35. The system of claim 1said system is configured to measure at least one of the following: painassociated with an addiction; predict rising pain levels; trackuterus-related pain or uterus contractions; epidural pain management;post-childbirth pain management; teething or other child-related pain;post-surgery pain; pain medication drug discovery; and neurologicaldisorders.
 36. The system of claim 1 for use in combination with a PCA(patent controlled analgesia) infusion pump for controlling the deliveryof medication to treat pain.
 37. The system of claim 1 wherein thecontroller includes telemetry circuitry to communicate informationindicative of the pain indicative signal to another device.
 38. A methodfor providing an indication of pain of a person such as measuring painor a surrogate of pain symptoms of a person, said method comprising:illuminating the tissue of the person; sensing light emitted orreflected by the tissue of the person; generating a light signalindicative of a light parameter of the sensed light; sensing anelectrical parameter of the tissue of the person; generating anelectrode signal indicative of an electrical parameter of the sensedelectrical parameter; sensing a temperature of the tissue of the person;generating a temperature signal indicative of the sensed temperature;processing the light signal, the electrode signal and the temperaturesignal and providing a pain indication signal which is a function of theprocessed signals; and providing an indication which is indicative ofthe pain indication signal.
 39. A system for cerebral monitoring of aperson, said system for use with the tissue of the person, said systemcomprising: A light source adapted for illuminating the tissue of theperson; A optical sensor adapted for sensing light emitted or reflectedby the tissue of the person, said optical sensor generating a lightsignal indicative of a light parameter of the sensed light; A surfaceelectrode adapted for sensing an electrical parameter of the tissue ofthe person, said surface electrode generating an electrode signalindicative of an electrical parameter of the sensed electricalparameter; A temperature sensor adapted for sensing a temperature of thetissue of the person, said temperature sensor generating a temperaturesignal indicative of the sensed temperature; One or more circuitsadapted for receiving the light signal, the electrode signal, and thetemperature signal and providing corresponding signals; A controlleradapted for receiving and processing the corresponding signals andadapted for providing a cerebral monitoring signal which is a functionof the corresponding signals; An indicator adapted to be responsive tothe controller for providing an indication which is indicative of thecerebral monitoring; and A power supply for supplying power to thesystem.